Kornimate/medical-research-clean huggingface dataset:
combivent vs. salbutamol in patients with metacholine induced bronchospasm

Conditions: Asthma

Summary: the purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.


Eligibility criteria:
inclusion criteria: * male or female patients with a diagnosis of asthma according to the american thoracic society criteria * patients aged 7 to 12 years inclusive * patients able to perform spirometry * patients with fev1 (forced expiratory volume in the first second) ≥ 80% of predicted normal value after saline * patients with pd20 (provocative dose that reduces fev1 by 20 %) metacholine lower than 8 mg/ml * patients or responsible relatives willing and able to sign an informed consent form exclusion criteria: * patients on treatment for or suspected as having glaucoma * patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients * patients suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum * patients with a history of chest surgery * patients with other respiratory conditions if diagnosed. these include pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of aids * patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen * patients who have been previously recruited into this study * patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study * patients with obvious or previously diagnosed serious hepatic or renal disease * patients who have been under the following drugs within the specified periods of time prior to determination of baseline fev1 or metacholine challenge * inhaled: * short acting β2 agonists: 6 hours * long acting β2 agonists: 12 hours * ipratropium bromide: 8 hours * dscg (disodium cromoglicate): 7 days * nedocromil: 7 days * oral: * short acting β2 agonists: 18 hours * anticholinergics: 7 days * short acting theophylline: 24 hours * long acting theophylline: 72 hours * antihistamines: 7 days * astemizole: 3 months * ketotifen: 3 months * inhaled or oral: other investigational drugs: 3 months * inhaled or oral: corticosteroids: 30 days
cesm abmr breast cancer screening trial

Conditions: Breast Cancer Screening

Summary: this is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast mri which have been recommended for biopsy. primary aim: measure and compare the diagnostic performance of cesm, abmr, and standard breast mri, using the following performance measures: cancer detection rate (cdr), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or ppv3). secondary aims: 1. compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (auc) for cesm, abmr, and standard breast mri. this will determine the feasibility of each modality as an alternative to standard breast mri and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities. 2. breast cancer characteristics (size, histologic subtype, node-positivity, ajcc stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).


Eligibility criteria:
inclusion criteria: * able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; * women aged ≥18 years at the time of enrollment * referred clinically for breast mri for any indication exclusion criteria: * known allergy or contraindication to iodinated contrast * are currently pregnant based on urine pregnancy test * have breast implants * are lactating
effect of pelvic floor and hip muscle strengthening in the treatment of stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: introduction: stress urinary incontinence is a common condition in women and can be defined as the involuntary loss of urine on exertion, exercise, sneezing or coughing. this pathology causes physical discomfort and impacts the quality of life in a negative manner. physiotherapeutic exercises is a treatment with low cost and high patient attendance. it can be applied with focus on strengthening the pelvic floor muscles or on muscular synergism. objective: to compare the effectiveness of kegel exercises performed alone or performed in association with the strengthening of the muscles of the hip in the treatment of stress urinary incontinence. methodology: the study is a randomized, blinded clinical trial. it aims at assessing objectively the strength of the pelvic floor, the improvement in the number of episodes of loss and impact on quality of life. the study will accept up to 40 women, who will be divided into two groups of physical therapy: group 1 (that will strengthen the pelvic floor muscles with kegel exercises) and group 2 (that will perform strengthening the pelvic floor muscles with kegel exercises associated with the strengthening of muscles of the hip). the two groups will be evaluated at the beginning and at the end of treatment.

the strength of the pelvic floor muscles will be evaluated with the aid of a perineometer

Eligibility criteria:
inclusion criteria: * women with 30 to 70 years of age; * clinical diagnosis of stress urinary incontinence; * urodynamic study. exclusion criteria: * stress urinary incontinence with sphincter deficiency; * urinary urgence; * mixed urinary incontinence; * pregnant women; * neurological or muscular disease that interfere with continence; * urinary infection; * genital prolapse; * gynecological surgery for urinary incontinence in the last year; * hormone replacement therapy; * strength 0 in functional evaluation of the pelvic floor muscles.
does the time between the end of vascular filling and evaluation of its effectiveness modify fluid challenge results in septic shock?

Conditions: Septic Shock

Summary: the main objective of this study is to evaluate in a population of patients with septic shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as "responders" to the fluid challenge (increase of at least 15% of itv in aortic) at the end of vascular filling (t10) and becoming "non-responders" 20 minutes after the end of the fluid challenge (t30) and whether this proportion is greater than 10 points.

the secondary objectives of this study are : a. to assess changes in different ultrasound parameters: e wave , e / a ratio , e / e ' in the event of vascular filling and construct a dose response curve for vascular filling. b. to determing a threshold value for the mitral e wave velcoity that can predict a positive response to volume expansion at t10 defined by a 15% increase in the sub aortic velocity time integral (itv) after 500 ml of crystalloids in 10 minutes. c. to determine a threshold value for theitv at t0 that can predict a positive response to volume expansion at t10 defined by a 15% increase in the itv after 500 ml of crystalloids in 10 minutes. d. to evaluate the proportion of responders at t10 becoming non-responders at t20. e. to evaluate the proportion of nonresponders at t10 and responders at t30 . f. to estimate the proportion of patients changing status regardless of the direction of change between t10 and t30 .

Eligibility criteria:
inclusion criteria: * the patient has given his/hers consent or the patient is in an emergency situation (commitment to obtain the consent of the patient as soon as his/her condition permits) * patient affiliated or beneficiary of a health insurance plan * patient with septic shock: proven or suspected infection associated with hypotension or lactate\> 4 mmol / l or organ dysfunction. hypotension despite fluid resuscitation of 20 to -40 ml / kg. * patient under controlled mechanical ventilation * patient requiring vascular filling according to the following criteria: * oliguria \<0.5 ml / kg / h for at least 2h * skin mottling * arterial lactate \> 2 mmol / l * svco2 \<70% or svo2 \<65% * patient on noradrenaline. exclusion criteria: * the patient is has in another interventional study that might change the results of this study within the past 3 months * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * the patient is pregnant, parturient, or breastfeeding * valvular pathology: grade iii and iv aortic or mitral insufficiency * non sinus electrocardiogram * non-echogenic patient * patient with any spontaneous breathing * moribund patient

Keywords: fluid challenge fluid resuscitation
diagnostic accuracy of dual-energy ct

Conditions: Osteoarthritis; Hand Osteoarthritis; Crystal; Deposit Joint; Crystals; Arthritis, Pyrophosphate; Crystals; Arthritis, Hydroxyapatite; Crystal Arthritis; Crystal Arthropathy of Hand

Summary: the study will include 20 people with hand oa awaiting surgery in the fingers. participants will undergo dual-energy ct, cone-beam ct, ultrasound, clinical examination, blood sampling and questionnaires. images will be analysed for the presence of joint-associated crystal including monosodium urate, calcium pyrophosphate and calcium hydroxyapatite. material obtained during surgery will be used for crystal verification and calculation of diagnostic accuracy of dual-energy ct and cone-beam ct.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. informed consent obtained. 3. patients with hand oa as defined by the american college of rheumatology classification criteria for hand oa: * hand pain, aching or stiffness and 3 or 4 of the following features: * hard tissue enlargement of ≥2 of the 10 selected joints\*. * hard tissue enlargement of ≥2 of the 10 dip joints. * fewer than 3 swollen mcp joints. * deformity of at least 1 of 10 selected joints\*. \*the 10 selected joints are the second and third dip, the second and third pip, and the first carpometacarpal joints of both hands. exclusion criteria: 1. known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, gout, psoriatic arthritis, psoriasis, inflammatory bowel disease), or other joint diseases (haemochromatosis) 2. positive anti-cyclic citrullinated peptide (\>10 ku/l) 3. known cutaneous deposition diseases (e.g. amyloidosis or porphyria). 4. foreign material/metallic implants at the area of interest will be excluded to avoid artefacts on cbct \[68\]. 5. other diseases in the area - e.g. skin disease, known previous fracture in the joint of interest. 6. participation in experimental device or experimental drug study 3 months prior to enrolment. 7. pregnancy or breast-feeding. 8. previous septic arthritis at the target joint. 9. previous surgical procedures at the target joint. 10. injection into the target joint within 3 months prior to enrolment. 11. inability to speak and read danish fluently. 12. treatment with colchicine within the last 30 days. 13. treatment with systemic steroids ≥7.5 mg prednisolone within the last 30 days. 14. lack of sample obtained for reference standard, i.e. unable to obtain either synovial fluid, joint lavage fluid, joint biopsy or excite joint. 15. any other condition that in the opinion of the investigator may interfere with study participation. there will be no restriction on sex or kellgren-lawrence (kl) grading.
aspects of breast-conserving surgery

Conditions: Breast Neoplasm; Cosmetic Outcome; Quality of Life

Summary: prospective study of cosmetic outcome and quality of life for women undergoing breast cancer surgery using patient a reported outcome measure (breast-q) and a computer program validated to assess cosmetic outcomes after breast cancer surgery (bcct.core) at baseline and on 1-year follow-up.

this is a clinical study with the aim to investigate how breast cancer patient's quality of life changes after breast cancer surgery, as well as looking at the cosmetic outcomes for the same patient group. the study is conducted prospectively, with patients being included forward in time when they are diagnosed with breast cancer in kristianstad hospital, sweden. the study started in january 2019 and is expected to continue enrollment for two years, with the aim of recruiting 300 patients. the patients fill out a quality of life questionnaire (breast-q) at baseline, which is defined as time of diagnosis, and second breast-q questionnaire 1-year post surgery. photos are also taken of the breasts both preoperatively and postoperatively and the photos are assessed by a computer program validated to assess cosmetic outcomes after breast cancer surgery, called bcct.core, and secondly the cosmetic results of the breasts are evaluated by the surgeon and patient herself on a 10-grade scale. in addition study specific items covering for example psychiatric comorbidity, bmi and smoking are retrieved. the study hypothesis is that patients undergoing breast cancer surgery overall have a good quality of life 1-year after their diagnosis, especially if they are treated with a surgical approach that takes into account both the best oncological treatment as well as the best surgical technique for cosmetic outcome, so called oncoplastic surgery. the other hypothesis is that cosmetic results will be overall favorable for the group of patients who are operated with breast-conserving techniques, and most favorable in those patients who have undergone oncoplastic surgery. secondly the study aims to see if there are other patient related variables that affect the quality of life or cosmetic outcome, for example cytostatic treatment, a high body mass index, smoking or psychiatric history prior to diagnosis.

Eligibility criteria:
inclusion criteria: * women with breast cancer diagnosed in central hospital of kristianstad from 1/1 2019 exclusion criteria: * patients who lack the ability to read and write swedish * patients that are not able to understand the information given * palliative care patients

Keywords: humans prospective studies breast neoplasms breast patient satisfaction patient reported outcome measures oncoplastic breast surgery follow-up studies mastectomy quality of life sweden
combined cognitive and vocational interventions after mild-to-moderate tbi: a randomized controlled trial

Conditions: Brain Injuries, Traumatic; Cognitive Impairment

Summary: a considerable number of patients with mild and moderate traumatic brain injury (tbi) experience long-lasting somatic, cognitive, and emotional symptoms that may hamper their capacity to return to work (rtw). although several studies have described medical, psychological and work-related factors that predict rtw after tbi, well-controlled intervention studies regarding rtw in this group are scarce. furthermore, there have traditionally been weak collaborations among rehabilitation services in the health sector, the labor and welfare administration (nav), and the work-places. the current project proposal describes an innovative randomized controlled trial (rct) which will explore the effect of combined manualized cognitive rehabilitation efforts and supported employment in real-life competitive work settings for patients who have not returned to work 8 weeks post-injury. the project combines the rehabilitation and vocational science perspectives; it involves multidisciplinary collaboration, and explores the efficacy of increased cross-sectorial collaboration between specialized health care services and the welfare system. if the intervention proves efficient, the project will further describe the cost-effectiveness and utility of the program, and thereby provide important information of use for policy makers. in addition, the study aims at generating knowledge on the rtw-process both for the persons with tbi, and their workplaces, and to disseminate this knowledge in order to create new multidisciplinary and collaborative practices. the project has potential to generate knowledge of relevance for other patients with neurological deficit.

please, see protocol article: https://www.ncbi.nlm.nih.gov/pubmed/29041954

Eligibility criteria:
inclusion criteria: * reside in oslo and akershus counties in norway * mild-to-moderate tbi (glasgow coma scale score 10-15 at injury site). confirmation of diagnosis of mild tbi will be done through documenting that acute symptoms adhere to the american congress of rehabilitation medicine's (acrm) definition of mild tbi. * loss of consciousness \<24 hours * posttraumatic amnesia (pta) \<7 days * employed in a minimum 50% position at the time of injury * sick listed at the 50% or higher level due to post-concussive symptoms 2 months post-injury exclusion criteria: * history of severe psychiatric or neurological illness * active substance abuse * inability to speak and read norwegian

Keywords: cognitive rehabilitation supported employment mild and moderate tbi return to work randomized controlled trial
long-term follow-up of subfoveal neovascular amd

Conditions: Exudative Age-related Macular Degeneration

Summary: treatment naive patients with subfoveal namd initially treated monthly with intravitreal anti-vegf and subsequently prn, will be included in this study. patients will be investigated for the first 2 years monthly and subsequently according to disease activity but at least every two months. patients will be examined with 4m bcva etdrs distance visual acuity, reading acuity measured by radner-reading-charts, contrast sensitivity by pelli-robson score, microperimetry and hd-oct.


Eligibility criteria:
inclusion criteria: * treatment naive subfoveal amd, written informed consent, able to read exclusion criteria: * choroidal neovascularisation due to other ocular diseases, mature cataract

Keywords: neovascular amd optical coherence tomography reading acuity contrast sensitivity
scheduled intranasal ketamine

Conditions: Pain; Trauma

Summary: the purpose of this research is to determine if scheduled intranasal ketamine effects opioid requirements in adult trauma patients with moderate to severe pain in the inpatient setting.


Eligibility criteria:
inclusion criteria: * patient between aged 18-80 years, present following a traumatic incident, rate pain \> 5 on the numeric rating scale (nsr), and require admission to the hospital. exclusion criteria: * - patients that arrive at facility intubated * patients that received ketamine in the field * patients less than 18 years old or greater than 80 years * pregnant or breast-feeding females * hemodynamic instability defined as need for vasoactive drugs or systolic blood pressure \>180 * weight less than 80 pounds or greater than 300 pounds * glasgow coma scale less than 15 * current acute head injury resulting in unconsciousness * current or history of eye injury * current or history of seizures * facial or nasal fractures that require nasal precautions * current or history of intracranial hypertension * history of schizophrenia * bac (blood alcohol content) greater than 0.08 * current alcohol abuse * current drug abuse or positive drug screen * chronic pain or patients on pain contracts * inability to assess pain intensity * contraindications or allergies to the treatment * patients with hepatic insufficiency * prisoners * nursing home residents * urine drug screen positive for illicit drugs or medications not on their home medication list. * bac \> 0.08 * positive pregnancy test
personalized inhibitory control training for compulsive behavior change

Conditions: OCD

Summary: obsessive-compulsive disorder (ocd) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform. it has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the ocd cycle. the main goal of the current proposal, which is based on exciting pilot data, is to test a novel computerized training program to create an association between ocd-related stimuli, which typically trigger the compulsive urge, and the brain system responsible for stopping. the idea is that once this system is triggered, it will be easier for patients to stop the compulsive urge.


Eligibility criteria:
inclusion criteria: * ocd patients exclusion criteria: * metal/ electronic device * under the age of 18 * pregnant women * tattoos that cover over 10% of body mass * chronically ill patients * psychosis/ bi-polar * substance abuse * sever depression * active suicide thoughts * hearing loss
magnetic resonance imaging for better selection of pancreatic cancer patients for surgery: a randomized clinical trial

Conditions: Pancreas Cancer

Summary: pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. the only curative treatment is surgery which is accompanied by great morbidity and mortality. recent research indicates that magnetic resonance imaging (mri) is superior in detecting liver metastases compared with today's gold standard computed tomography (ct), which usually is a contraindication to surgery. investigators want to randomize patients with pancreatic cancer, who are eligible for surgery to a pre-operative mri. the investigators want to examine if mri is as good for the staging as ct and if mri is better for the identification of liver metastases. patients will have a follow-up period of 1 year to see if mri changes the overall survival.

currently, ct is the state of art for assessing and staging pancreatic cancer. however, it has its limitations when it comes to detecting small liver metastases, which are often found in pancreatic cancer. recent research indicates that mri is superior to ct when it comes to the detection of liver metastases. thus, the investigators want to examine mri's role in the assessment of pancreatic cancer. the investigators want to conduct a nationwide rct to examine the feasibility of using mri for tumor staging and identification. the overall aim is to improve the selection of patients going to surgery so futile resections are avoided and increase the overall survival. patients who are deemed eligible for pancreatic resection after being reviewed at a local multidisciplinary tumor board will be, upon consent, electronically randomized to one of two treatment arms (each arm will contain 100 patients). patients within the control arm will as per usual proceed to surgery, whereas patients in the intervention arm will receive a pre-operative mri scan. the mri will be read by experienced gastroenterology radiologists who are blinded to the patient's identity and the initial ct findings. treatment will be based on mri findings. there will be a follow-up period of 1 year to see if mri changes the overall survival. within this rct we will conduct three studies. study 1) the investigators want to compare pancreatic tumor staging with mri versus standard upper abdominal ct, we hypothesize that mri is not inferior to ct. study 2) the investigators want to assess mri's ability to detect liver metastases vs standard upper abdominal ct, in patients otherwise deemed eligible for surgery. we hypothesize that mri is superior to ct in the detection of liver metastases. study 3) the investigators want to assess the impact of mri, thus patients will be followed for 1 year. we want to see if mri changes the overall survival, treatment allocation, and recurrence.

Eligibility criteria:
inclusion criteria: * must be eligible for curative pancreatic resection based on ct * must accept randomization exclusion criteria: * not eligible for curative pancreatic resection * unable to undergo mri. * did not accept randomization.

Keywords: magnetic resonance imaging (mri) computed tomography (ct)